Consumer Safety Advisories > ADR that result in revision of patient information

ADR that result in revision of patient information   Update of Rotarix Oral Vaccine package insert   US Food and Drug Administration (FDA) has approved the contraindications section of the U.S. package insert for Rotarix Oral Vaccine, to include infants with Severe Combined Immunodeficiency Disease (SCID), because of post-marketing reports describing severe gastroenteritis and vaccine viral shedding in these patients. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201636.htm Situation in Hong Kong: Rotarix is registered by Glaxosmithkline Ltd. in HK. The company will follow up with its head office regarding the above issue. Ends/Thursday, February 25, 2010 Issued at HKT 11:00   Related Information: Singapore: Risk of intussusception following rotavirus immunisation in Singapore Posted 2015-10-08 Australia: Rotavirus vaccination and the risk of intussusception Posted 2013-08-28 Singapore: An update on the risk of intussusception with rotavirus vaccines Posted 2011-08-23 The United States: Approval Letter – Rotarix: Updated Package Insert and Patient... Posted 2011-03-04 Australia: Rotavirus Vaccination and Risk of Intussusception Posted 2011-02-28 The United States: FDA actions on Rotarix and RotaTeq Posted 2010-12-29 European Union: European Medicines Agency confirms positive benefit-risk balance... Posted 2010-09-24 European Union: European Medicines Agency confirms positive benefit-risk balance... Posted 2010-07-23 Use of rotavirus vaccines resumes Posted 2010-05-17 Recall of RotaTeq vaccine Posted 2010-05-07 Recall of Rotarix Posted 2010-03-23